04.22.16 From ClinicalTrials.gov
Clinical studies are designed to generate the evidences needed to bring safe and efficient medicine to patients.
Hence participating in a clinical study contributes to medical knowledge. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions.
On the average 10 to 12 years are needed to develop a new medicine. Clinical trials are the longest and most difficult part of that process. According to PhRMA, only 12% of compounds that enter clinical trials are ever approved for use by patient.
To better understand how a clinical trials is designed, how it is conducted, for how long and with which purpose, several official authorities put together pedagogical Q&A’s, such as the WHO, the FDA or the PhRMA through videos like this one:
Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.
Phase I is a first test of several months on a small group of healthy volunteers and people with condition (especially in cases such as cancer therapies).
70% of the drugs tested in phase I move to phase II when several hundred people with the condition are observed for up to 2 years.
A third of them moves to the several years long phase III when efficacy and potential adverse reactions are monitored on up to 3,000 participants300 to 3,000 volunteers who have the disease or condition.
Researchers design Phase III studies to demonstrate whether or not a product offers a treatment benefit to a specific population.
If 25% to 30% of the new treatments tested in phase III move to the next stage and can seek approval from international and local authorities to enter relevant markets, it’s not the end of the clinical trial per say: once approved several thousand volunteers who have the disease are specifically monitored for safety and efficacy.
read the article on ClinicalTrials.gov
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